Adenoma Colon
Conditions
Brief summary
Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.
Detailed description
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch
Interventions
DEVICEclip-traction
A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* a lesion in the colon or rectum suitable for removal by the ESD technique
Exclusion criteria
* dementia * inability to understand the written study information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resection speed (mm2/min) | Within completion of procedure | Measured as area of the removed lesion divided by procedure time. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORRichard Marsk, MD,PhD
Karolinska Institutet
Outcome results
None listed